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Post by vdexdiabetes on Dec 28, 2017 17:51:03 GMT -5
At the risk of opening the kimono too much, let me say that Vdex is NOT set up as a charity or a vehicle to pump up the stock price of MNKD, but is very much a profit-making endeavor. We believe, in fact, we have proven, that our model will be quite profitable. That said, our first concern when we organized the company was an evaluation of Afrezza and the design of protocols to best use the product. We've learned a ton. Afrezza is every bit as good as Al Mann said it was, and actually a little better (I'll leave details on that point for a later post). We have played with different protocols and have developed our own after some trial and error. Suffice to say, we are highly confident about improving blood sugar control with virtually every diabetic. That's not to say we're so wonderful, but rather because Afrezza is. What Vdex contributes are protocols for the best way to use Afrezza. It has been mentioned before but bears repeating, Afrezza is not the easiest product to use correctly. There is a learning curve. We know; we traveled it. But the effort is clearly worth it. There is simply no better way to manage blood sugar, in our opinion, than with Afrezza. Like all new endeavors, Vdex has had its share of bumps. We have been resolute in our approach because its quite clear that something has to change in the treatment of diabetes. Our goal is to make that change happen. We are now at a point where we can begin our expansion in earnest. I don't want to set false expectations, but we do not intend to merely operate a few centers in Southern California. Our sights are set considerably higher. We know there will be challenges dand that we will make mistakes. That's entrepreneurship. We don't fear that; we embrace it. Have you been collecting statistics on your clinical population (A1c, time in range)? Will it be used in marketing? or published? Yes, and we have some very impressive stats on both A1c reduction (with no hypos) and time in range. Using this info in marketing gets a bit dicey. Our Medical Advisory Board is not totally comfortable with stats gathered in the regular course of the practice because we don't have controls in place like one would in a structured study. Anything that we publish needs to be able to withstand scrutiny. We're planning to put in place some structure that allows us to publish. That will occur in the months ahead. I can say with no hesitancy that we'll have results that simply are not possible to obtain without Afrezza and our protocols. |
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Post by sayhey24 on Dec 28, 2017 18:43:48 GMT -5
Have you been collecting statistics on your clinical population (A1c, time in range)? Will it be used in marketing? or published? Yes, and we have some very impressive stats on both A1c reduction (with no hypos) and time in range. Using this info in marketing gets a bit dicey. Our Medical Advisory Board is not totally comfortable with stats gathered in the regular course of the practice because we don't have controls in place like one would in a structured study. Anything that we publish needs to be able to withstand scrutiny. We're planning to put in place some structure that allows us to publish. That will occur in the months ahead. I can say with no hesitancy that we'll have results that simply are not possible to obtain without Afrezza and our protocols. One of the biggest challenges PWDs seem to face is insurance coverage. I am assuming you have a trick or two as part of your protocol in getting the PWD insurance. About what percent of your patients are being covered? IMO the need for controlled studies at this point is dwarfed by your clinical results if they are as good as you say, and I have no reason to doubt you. Its pretty hard to argue with a pre/post afrezza AGP chart as the numbers don't lie. Your results combined with a profitable business model should allow investment for at least 100 clinics by year-end 2018. Assuming each clinic can do 10 new RXs per week, VDex alone should be doing 2X what the rest of medical community is currently doing. Thinking out loud, 2018 could finally be the year of afrezza and not the year of the dog. |
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Post by nylefty on Dec 28, 2017 21:42:19 GMT -5
Yes, and we have some very impressive stats on both A1c reduction (with no hypos) and time in range. Using this info in marketing gets a bit dicey. Our Medical Advisory Board is not totally comfortable with stats gathered in the regular course of the practice because we don't have controls in place like one would in a structured study. Anything that we publish needs to be able to withstand scrutiny. We're planning to put in place some structure that allows us to publish. That will occur in the months ahead. I can say with no hesitancy that we'll have results that simply are not possible to obtain without Afrezza and our protocols. Your results combined with a profitable business model should allow investment for at least 100 clinics by year-end 2018. Assuming each clinic can do 10 new RXs per week, VDex alone should be doing 2X what the rest of medical community is currently doing. Thinking out loud, 2018 could finally be the year of afrezza and not the year of the dog. Seriously? Think about the man and woman power and the capital it would take to open an average of two new locations every week. I'd be happy with one new location every month in 2018. |
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Post by sportsrancho on Dec 28, 2017 21:52:35 GMT -5
We have enough mankind longs interested to open up two in every state. Or more:-)
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Post by uvula on Dec 28, 2017 23:13:30 GMT -5
We have enough mankind longs interested to open up two in every state. Or more:-) Yes we are interested. Unfortunately we cannot afford to (any more). |
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Post by vdexdiabetes on Dec 28, 2017 23:52:32 GMT -5
Yes, and we have some very impressive stats on both A1c reduction (with no hypos) and time in range. Using this info in marketing gets a bit dicey. Our Medical Advisory Board is not totally comfortable with stats gathered in the regular course of the practice because we don't have controls in place like one would in a structured study. Anything that we publish needs to be able to withstand scrutiny. We're planning to put in place some structure that allows us to publish. That will occur in the months ahead. I can say with no hesitancy that we'll have results that simply are not possible to obtain without Afrezza and our protocols. One of the biggest challenges PWDs seem to face is insurance coverage. I am assuming you have a trick or two as part of your protocol in getting the PWD insurance. About what percent of your patients are being covered? IMO the need for controlled studies at this point is dwarfed by your clinical results if they are as good as you say, and I have no reason to doubt you. Its pretty hard to argue with a pre/post afrezza AGP chart as the numbers don't lie. Your results combined with a profitable business model should allow investment for at least 100 clinics by year-end 2018. Assuming each clinic can do 10 new RXs per week, VDex alone should be doing 2X what the rest of medical community is currently doing. Thinking out loud, 2018 could finally be the year of afrezza and not the year of the dog. Sayhey you are correct that insurance is one of the challenges, but surprisingly, we don't find it that tough to surmount. I don't have precise numbers in front of me, but my guess is that better than 80% of our patients get covered eventually. For competitive reasons, I'll be a little vague about how we do it. It can be a little time-consuming and for that reason, most traditional medical practices won't likely bother. Plus, we had to figure some of it out on our own. It was a similar process as with our treatment protocols in this respect: we knew the basics about how to prescribe and treat patients, but we learned through trial and error how to get better results by doing some things differently. Same with insurance coverage. Regarding our expansion, again, we had to try different things there as well. Here I'll say almost nothing for competitive reasons except this: we had initial ideas, tried them, found they didn't work, and evolved. The whole Vdex experience has required us to think outside the box after we tried something obvious and failed at it. That's why this has taken longer than all of us have wanted. We have been sustained by our belief in Al Mann, Afrezza, and the desire to do something meaningful for PWD. And, the support of so many on this board has certainly helped during some of the darkest moments. |
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Post by uvula on Dec 29, 2017 8:41:21 GMT -5
"For competitive reasons, I'll be a little vague about how we do it. It can be a little time-consuming and for that reason, most traditional medical practices won't likely bother. Plus, we had to figure some of it out on our own."
On the one hand this is great. I'm glad VDEX exists.
On the other hand this says a ton about past and present mnkd management. Shouldn't mnkd be the expert on all things related to afrezza?
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Post by xanet on Dec 29, 2017 8:48:49 GMT -5
"For competitive reasons, I'll be a little vague about how we do it. It can be a little time-consuming and for that reason, most traditional medical practices won't likely bother. Plus, we had to figure some of it out on our own." On the one hand this is great. I'm glad VDEX exists. On the other hand this says a ton about past and present mnkd management. Shouldn't mnkd be the expert on all things related to afrezza? Wasn't insurance access the point of rolling out Mannkind Cares? Management has been proactive on this for a long time, but it's a complex system to navigate and it's nice to have additional players in motion. |
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Post by akemp3000 on Dec 29, 2017 8:49:52 GMT -5
To VDex: Al Mann would be so proud of you and your dedication to fighting the fight, overcoming the countless challenges of a start-up and seeing this through. You deserve tremendous success moving forward. Keep your foot on the gas!
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Post by dg1111 on Dec 29, 2017 9:29:34 GMT -5
To VDex: Do you know if the sales at your facilities are accounted for in the Symphony data? In the past there has been some speculation that your offices are not a traditional pharmacy, and therefore they may not be included. Thank you.
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Post by sayhey24 on Dec 29, 2017 9:41:09 GMT -5
Your results combined with a profitable business model should allow investment for at least 100 clinics by year-end 2018. Assuming each clinic can do 10 new RXs per week, VDex alone should be doing 2X what the rest of medical community is currently doing. Thinking out loud, 2018 could finally be the year of afrezza and not the year of the dog. Seriously? Think about the man and woman power and the capital it would take to open an average of two new locations every week. I'd be happy with one new location every month in 2018. If VDexdiabetes can show in clinical results what Al Mann said for years and what Ralph DeFronzo is now saying he is doing with his Qatar study which is the progression in T2s can be stopped and potentially reversed, I am not sure capital is an issue. Now, in my area we are seeing a mad rush to open up urgent care clinics. We have more of them now than McDonalds. None, treat chronic diseases but all know how to give a BG test. Few in my area have full time doctors. Most are contracted by the hour and many seem to have left private practice after selling out to a big hospital group, working for the corporation for a few years and got frustrated with all the rules and paper work. What I am saying is the man/woman power is already in place along with the standing clinic. Its really just a sales effort doing the deal with the urgent care owner to set aside a corner of the clinic and to poke everyone's finger coming through the door and to send those that may even be a little high to the VDex corner. 2017 was the year of the CGM and Monitoring. We now have more monitoring companies and more on the way like onduo.com. Monitoring is great but eventually you have to solve the problem and if VDex can show they can and they can't be stopped by traditional BP tactics then 100 clinics I would say is a conservative number. The questions are; is the VDex business model sound; and are the clinical results as good as VDexdiabetes is saying. Assuming they are and I have no reason to doubt VDexdiabetes then as Sports said 2 per state gets you to 100 and that sounds conservative. I am thinking a VDex booth at ADA in Orlando displaying their results might get some attention and piss a few people off. As we have all been told forever, diabetes is a progressive disease until now especially if we treat early in the diagnosis. What are the current diabetes/prediabetes numbers in the U.S. - over 100M? I am not sure each clinic can service 1M PWDs, they may need more clinics. |
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Post by agedhippie on Dec 29, 2017 10:25:03 GMT -5
I am thinking a VDex booth at ADA in Orlando displaying their results might get some attention and piss a few people off. As we have all been told forever, diabetes is a progressive disease until now especially if we treat early in the diagnosis. What are the current diabetes/prediabetes numbers in the U.S. - over 100M? I am not sure each clinic can service 1M PWDs, they may need more clinics. There are two problems you run into almost immediately with that approach. The first is that doctors will say that VDex results are the result of intensive management and if they could spend that amount of time they could get similar results (as an aside this is a known problem with trials - the higher level of attention from the medical support staff produce better results regardless which makes the control arm important). Secondly that you cannot simply publish practice results and expect to be taken seriously. As VDex said the Medical Board will have problems with that and rightly so. You cannot take a self-selected well motivated group and expect that to translate to the wider population. To prove a protocol you need control groups and blind tests. I suspect that the VDex protocol would hold up, however that sort of trial is expensive and there is not much gain in it for VDex. |
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Post by straightly on Dec 29, 2017 10:43:47 GMT -5
Have you been collecting statistics on your clinical population (A1c, time in range)? Will it be used in marketing? or published? Yes, and we have some very impressive stats on both A1c reduction (with no hypos) and time in range. Using this info in marketing gets a bit dicey. Our Medical Advisory Board is not totally comfortable with stats gathered in the regular course of the practice because we don't have controls in place like one would in a structured study. Anything that we publish needs to be able to withstand scrutiny. We're planning to put in place some structure that allows us to publish. That will occur in the months ahead. I can say with no hesitancy that we'll have results that simply are not possible to obtain without Afrezza and our protocols. This reminded me of a quote from a movie I again ask for a source which goes "even that shall pass". Recently, the Chinese government announced that, qualified medication and medical devices from abroad can be approved for marketing in China, while monitoring and collecting safety data. I know our FDA is more dignified and less digitized than that, but who knows, even that may pass. |
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Post by zuegirdor on Dec 29, 2017 13:04:18 GMT -5
en.wikipedia.org/wiki/This_too_shall_passI knew a Jewish man who had "this too shall pass" printed on the inside of a ring he wore. It would seem a faint comfort in that it glimpses the ultimate passing. But context of the moment is important too and so I live by those words as context allows.
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Post by factspls88 on Dec 29, 2017 15:21:39 GMT -5
At the risk of opening the kimono too much, let me say that Vdex is NOT set up as a charity or a vehicle to pump up the stock price of MNKD, but is very much a profit-making endeavor. We believe, in fact, we have proven, that our model will be quite profitable. That said, our first concern when we organized the company was an evaluation of Afrezza and the design of protocols to best use the product. We've learned a ton. Afrezza is every bit as good as Al Mann said it was, and actually a little better (I'll leave details on that point for a later post). We have played with different protocols and have developed our own after some trial and error. Suffice to say, we are highly confident about improving blood sugar control with virtually every diabetic. That's not to say we're so wonderful, but rather because Afrezza is. What Vdex contributes are protocols for the best way to use Afrezza. It has been mentioned before but bears repeating, Afrezza is not the easiest product to use correctly. There is a learning curve. We know; we traveled it. But the effort is clearly worth it. There is simply no better way to manage blood sugar, in our opinion, than with Afrezza. Like all new endeavors, Vdex has had its share of bumps. We have been resolute in our approach because its quite clear that something has to change in the treatment of diabetes. Our goal is to make that change happen. We are now at a point where we can begin our expansion in earnest. I don't want to set false expectations, but we do not intend to merely operate a few centers in Southern California. Our sights are set considerably higher. We know there will be challenges and that we will make mistakes. That's entrepreneurship. We don't fear that; we embrace it. From where do you get your patients? Are they on a walk-in basis or do you get referrals from PCP's or Endos who do not have the time or know how to school patients on Afrezza usage/titration? If you do not get referrals, do you have any plans to implement a program to build awareness amongst these physicians and generate increased traffic? |
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